Kornimate/medical-research-clean huggingface dataset:
local vs systemic methotrexate in management of uterine ectopic pregnancy

Conditions: Local; Systemic; Methotrexate; Uterine Ectopic Pregnancy

Summary: this study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hcg) clearance and need for further management options.

ectopic pregnancy is considered a life-threatening condition which requires immediate intervention. owing to the advancements in medical technology, ectopic pregnancy can now be diagnosed in the early stages. methotrexate (mtx) is an antimetabolite drug showing a competitive reversible binding concerning natural dihydrofolates and acting as an inhibitor of the dihydrofolate-reductase (dhfr), a key enzyme synthesizing the tetrahydrofolates needed for the synthesis of purine and pyrimidine rings.

Eligibility criteria:
inclusion criteria: * age from 20 to 40 years. * women with uterine ectopic pregnancy (interstitial pregnancy, cervical pregnancy, or cesarean scar pregnancy). * gestational age is less than 9 weeks, the embryo size is smaller than 10 mm, and the serum beta-human chorionic gonadotropin (β-hcg) levels are less than 10,000 miu/ml. exclusion criteria: * patients with basal beta hcg levels less than 1500 miu/ml. * any contraindications to mtx as a hepatic disorder, renal disorder and thrombocytopenia * diabetes mellitus. * severe vaginal bleeding or hemodynamic changes or hemoperitoneum. * history of cancer. * ascites. * pleural effusion.
rtms for mdd: 5.5cm rule vs. f3 targeting

Conditions: Major Depressive Disorder; Depression

Summary: the purpose of this study is to examine the effects of different treatment locations using repetitive transcranial magnetic stimulation (rtms) to treat major depressive disorder.

currently there is little standardization between rtms treatment programs as to what is the best way to localize the left dorsolateral prefrontal cortex, which is the fda-approved treatment location for clinical rtms for major depressive disorder (mdd). different targeting methods yield locations that can vary by up to a few centimeters. by comparing different treatment locations and obtaining neurobehavioral, neuroimaging, cognitive, and neuropsychological measures, this study would provide the opportunity to identify the optimal treatment targeting method when using rtms for major depressive disorder in a clinical setting. this study will specifically be focusing on comparing the two most common targeting methods: a target 5.5cm anterior to the motor strip on the left prefrontal scalp and the f3 target location on the left prefrontal scalp as identified using the 10-20 eeg system nomenclature.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder * age between 18 and 90 years * rtms is clinically indicated as determined by clinical rtms physician team at university of iowa exclusion criteria: * rtms contraindication such as implanted ferromagnetic material in the head or history of epilepsy with poorly controlled seizures * mri exclusion criteria (if participating in mri portion of study) including implanted device such as: * pacemaker * coronary stent * defibrillator * neurostimulation * or any of the following conditions: * claustrophobia * uncontrolled high blood pressure * poorly controlled atrial fibrillation * significant heart disease * hemodynamic instability * severe kidney disease * pregnant, trying to become pregnant, or breast feeding

Keywords: transcranial magnetic stimulation rtms f3 5.5cm rule targeting tms
different surgical modalities in the management of pelvi-ureteric junction obstruction

Conditions: Pelvi-ureteric Junction Obstruction

Summary: the study compared open pyeloplasty (op) and laparoscopic pyeloplasty (lp) for treating pelvi-ureteric junction obstruction (pujo) in 40 patients.


Eligibility criteria:
inclusion criteria: * age between 7 months and 60 years. diagnosed with pelvi-ureteric junction obstruction (pujo). glomerular filtration rate (gfr) greater than 10 ml/min. open to both genders. exclusion criteria: * active infection. gfr less than 10 ml/min. presence of a single kidney. patients with kidney or multiple congenital anomalies. pregnancy.
investigation of the ability of the tena smartcare change indicator to reduce the number of manual checks between changes of absorbing incontinence products

Conditions: Urinary Incontinence

Summary: the purpose of this post market clinical investigation is to demonstrate the performance and safety of the tena smartcare change indicator.

the tena smartcare change indicator is intended for use on individuals, dependent end user (deu), suffering from urinary incontinence (ui) who are cared for in a home environment, by one or more caregivers (cgr). the tena smartcare change indicator is an accessory to tena absorbing incontinence products. this clinical investigation is intended to demonstrate that use of tena smartcare change indicator has the ability to reduce the number of manual checks between daily changes of absorbing incontinence products. secondarily, the investigation will evaluate number of leakages, skin redness, usability and fecal incidence. furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.

Eligibility criteria:
inclusion criteria: 1. deu is diagnosed with urinary incontinence managed with a tape-style incontinence product. 2. deu is unable to sufficiently communicate the need for an incontinence product to be changed. 3. deu is being cared for in a home environment and most of the care is provided by a main cgr. 4. deu is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the deu. note, the legally designated representative and main cgr cannot be the same person. 5. cgr is willing and able to provide informed consent to participate in the clinical investigation. 6. the cgr frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process. 7. if incontinence is managed by pharmaceuticals, the dose regime is stable. 8. deu and cgr ≥ 18 years of age. exclusion criteria: 1. deu is cared for in a professional establishment or is institutionalized. 2. deu has ≥ 4 fecal "incidences" per week. 3. deu has severe incontinence product related skin problems, as judged by the investigator. 4. deu has any type of urinary catheter(s) resulting in improved/treated urinary incontinence. 5. the incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks. 6. any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator. 7. cgr is incapable or unwilling to use the required smart phone application and/or the diary registration webpage required for the clinical investigation. 8. participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation. 9. deu is pregnant or nursing. 10. cgr or deu with an alcohol or drug addiction
conmed beamer study

Conditions: Gastrointestinal Neoplasms; Achalasia; Gastroparesis

Summary: this is a prospective registry of all patients who endoscopic submucosal dissection (esd), per-oral endoscopic myotomy (poem) and gastric per-oral endoscopic myotomy (g-poem) using conmed electrosurgical unit for submucosal dissection at baylor st luke's medical center. collected information includes; procedure technical success rate, duration, periprocedural complications and ease of use.

submucosal endoscopy is a novel subset of procedures which enables endoscopist to utilize the submucosal space to perform advanced endoscopic procedures. the submucosa is the third layer of the gastrointestinal wall and it is a potential space which is expandable upon injecting the submucosa with fluid. the expanded submucosa causes a significant lift which enable dissection of the submucosal space with the removal of the overlying polyp or early cancer. the submucosal space can be also utilized to create a longitudinal submucosal tunnel in the esophagus or the stomach wall which allows for performing lower esophageal sphincter or pyloric myotomy for the treatment of achalasia or gastroparesis. currently, the most commonly performed submucosal endoscopy procedures are endoscopic submucosal dissection (esd) for removal of early cancers or polyps throughout the gastrointestinal tract, per-oral endoscopic myotomy (poem) for treatment of achalasia, or gastric per-oral endoscopic myotomy for the treatment of gastroparesis. all of the above procedures require a specialized electrosurgical unit (esu) which generate high frequency current to help incision (cutting) of the mucosa and dissection (coagulation) of the submucosa. the conmed beamer is a novel esu with tissue sensing property which expedites the process of submucosal dissection. the device is currently approved for clinical use in the us. the purpose of this study is to create registry for all submucosal endoscopy procedures performed using conmed beamer device at bslmc with focus on clinical outcomes of the procedure including adverse events.

Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years old * patient is capable of providing informed consent * patient is referred for endoscopic submucosal dissection, per-oral endoscopic myotomy, or gastric per-oral endoscopic myotomy exclusion criteria: * patient is \< 18 years old * patient refused and/or unable to provide consent * patient is a pregnant woman

Keywords: endoscopic submucosal dissection per-oral endoscopic myotomy (poem) gastric per-oral endoscopic myotomy (g-poem)
administration of human protein c concentrates in patients with sepsis and septic shock.

Conditions: Sepsis; Septic Shock

Summary: the purpose of this study is to investigate the effects on systemic hemodynamics, microcirculation and organ function of human protein c concentrate in patients with sepsis and septic shock.

sixty septic patients with plasma protein c activity \< 60 % will be enrolled in the study. patients will be randomly allocated to be treated with either a) a continuous infusion of human protein c concentrate at 3 ui/kg/hr for 72 hours to reach plasma protein c activity between 70 and 120 % b)to a continuous infusion of activated protein c at 24 micrograms/kg/hr for 96 hours, c) a standard teatment(control; each n = 20). in all groups, norepinephrine will be titrated to achieve a mean arterial pressure (map) between 65 and 75 mmhg. data from right heart catheterization, from microcirculation (sdf imaging) and from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72 hours.

Eligibility criteria:
inclusion criteria: * severe sepsis or septic shock with plasma activity of protein c \< 60 % exclusion criteria: * pregnancy * risk of bleeding * hemorragia * age \< 18

Keywords: human protein c activated protein c microcirculation septic shock sepsis
regn3918 in patients with paroxysmal nocturnal hemoglobinuria (pnh) to evaluate its long term safety, efficacy and tolerability.

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the primary objective of the study is to evaluate the long-term safety, tolerability, and effect on intravascular hemolysis of regn3918 in patients with paroxysmal nocturnal hemoglobinuria (pnh). the secondary objectives of the study are: * to evaluate the long-term effect of regn3918 on intravascular hemolysis * to assess the concentrations of total regn3918 in serum * to evaluate the occurrence of the immunogenicity of regn3918


Eligibility criteria:
key inclusion criteria: • patients with pnh who have completed, without discontinuation, study treatment in one of the parent studies in which they participated (either r3918-pnh-1852 \[nct03946748\] or r3918-pnh-1853) key exclusion criteria: * significant protocol deviation(s) in the parent study based on the investigator's judgment and to the extent that these would (if continued) impact the study objectives and/or safety of the patient (for example, repetitive non-compliance with dosing by the patient) * any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study note: other protocol defined exclusion criteria apply

Keywords: pnh
diet, exercise, and nutrition challenges in mexican adults during covid-19: a study

Conditions: COVID19 Disease

Summary: the covid-19 pandemic was particularly devastating in developing countries such as mexico, where the nation reported some of the highest covid-19 cases and a high prevalence of obesity. this study aimed to evaluate the food consumption among mexican adults during the covid-19 pandemic. a cross-sectional study was conducted, involving 1,082 mexican adults recruited through online invitations containing a link to complete a survey. a 48-item questionnaire was designed to assess the frequency of food consumption and sociodemographic characteristics in a semi-quantitative manner. a retrospective instrument was used to evaluate physical activity (days/week and duration).

the covid-19 pandemic had a particularly harsh impact on developing countries like mexico, which reported some of the highest numbers of covid-19 cases and a significant prevalence of obesity. this study aimed to examine the eating habits of mexican adults during the covid-19 pandemic. a cross-sectional survey was conducted, involving 1,082 mexican adults who were recruited via online invitations that included a link to complete a questionnaire. a 48-item survey was created to evaluate the frequency of food consumption and sociodemographic factors semi-quantitatively. physical activity was assessed using a retrospective tool to measure the frequency and duration of exercise per week. the main discovery identified two dietary patterns: industrialized and healthy. the industrialized dietary pattern was more common and included the consumption of sugary dairy products, sugary drinks, alcoholic beverages, sweets, fried foods, and both red and processed meats. men consumed significantly more ultra-processed foods (22.5%) compared to women (15.45%) based on a 2000 kcal diet. in addition, participants did not meet the recommended intake levels for fruits, vegetables, legumes, and natural dairy products. intake of sugary drinks was three times higher than recommended for both genders. regarding physical activity, only 29.7% of participants reported engaging in adequate physical activity. the study also highlighted insufficient consumption of nuts and an excessive intake of red and processed meats. it underscored the necessity for intervention and educational initiatives to improve dietary choices, particularly among younger populations.

Eligibility criteria:
inclusion criteria: additional to the age, people living in mexico during the covid pandemics. exclusion criteria: people who did not live in mexico during the covid pandemics -

Keywords: sars cov-2 frequency of intake dietary patterns ultraprocessed foods mexican population
diagnosis of coronary artery disease in high risk diabetic patients

Conditions: Diabetes Mellitus

Summary: the aim of this study is to determine in high risk diabetics if the positive predictive value of stress echocardiography is superior to the positive predictive value of stress scintigraphy in the diagnosis of coronary stenosis \> 50%.

comparison between stress echocardiography and stress scintigraphy in the detection of silent myocardial ischemia

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients in women\> 60 yo or men \> 55 yo, with high risk of coronary artery disease (ef \< 40%, ecg abnormalities, renal failure , 2 others risk factors of atherosclerosis) exclusion criteria: * previous documented cad acute coronary syndrome

Keywords: coronary artery disease stress myocardial scintigraphy stress echocardiography
effectiveness of splinting after collagenase injection

Conditions: Dupuytren Contracture; Dupuytren's Disease

Summary: dupuytren disease is a fibroproliferative condition of the palmar and digital fascia. a collagen containing cord forms which can lead to fixed flexion contracture of one or more fingers. while there is no cure, many treatment options are available to manage symptoms. one of these options is injectable collagenase clostridium histolyticum (cch). cch is a combination of two highly selective microbial collagenases that can disrupt collagen types i and iii usually found in cords. current standard of care after receiving a cch injection is daily hand exercises and use of a static night brace for four months. however, there is limited evidence that use of a night splint after cch injection has any benefit post-treatment. the goal of our randomized, controlled trial, is to determine the clinical effectiveness of splinting after cch injection. study subjects will be adults 18 years of age or older with dupuytren disease and contracture of one or more digits. treatment includes collagenase clostridium histolyticum injection for dupuytren flexion contraction, with randomization to static night splint or no splint.

patients with dupuytren disease that meet inclusion criteria will be consented to participate. all patients will be randomized to splint or no splint group prior to treatment. baseline data will be collected prior to treatment and will include demographics, measurement of joint flexion contracture(s) with a standard finger goniometer, and quickdash scores. all patients that participate will receive 1 injection of 0.58 mg of cch into cord. after 24-48 hours, if needed, patient will return to clinic for extension manipulation of treated finger(s) to help facilitate rupture of cord. following injection and/or manipulation, all patients will be instructed to perform a series of finger exercises daily that they will receive from a hand therapist. in addition, patients assigned to the splint group will be fitted for a static night splint that they will be instructed to wear nightly for 4 months. splint compliance will be recorded by a survey at each follow up visit. patients will return to clinic for routine follow up care at 1 month and 4 months during which their degree of contracture(s) and outcomes will be measured and recorded. the primary outcome measures of this study are improvement in active extension deficit of each joint and total active extension of each digit, in degrees. the secondary outcome measures are quickdash scores and patient satisfaction.

Eligibility criteria:
inclusion criteria: * age 18 years or older * contracture of 1 or more digits caused by palpable cord * pip joint flexion contracture of 20 degrees or more or; * mcp joint flexion contracture of 20 degrees or more exclusion criteria: * age less than 18 years * prior cch injection for contracture less than 1 year before start of study * prior surgical intervention for contracture less than 1 year before start of study
a retrospective natural history study of patients with lysosomal acid lipase deficiency/wolman phenotype

Conditions: Lysosomal Acid Lipase Deficiency; Wolman Disease

Summary: this is a natural history study to characterize key aspects of the clinical course of lysosomal acid lipase (lal) deficiency/wolman phenotype in patients.

the objective of this study is to characterize key aspects of the clinical course of lal deficiency/wolman phenotype in patients including, but not limited to, survival and growth parameters, to serve as a historical control to inform the evaluation and care of affected patients and to provide a reference for efficacy studies of enzyme replacement or other novel therapies.

Eligibility criteria:
inclusion criteria: * deceased patients diagnosed with lal deficiency/wolman phenotype in 1985 or later provided they have required data points in their medical records. exclusion criteria: * patients will be excluded from the study if the required data points for inclusion are not available. * living lal deficiency/wolman phenotype patients will be excluded

Keywords: lal deficiency lipa wolman disease wolman phenotype early onset lal deficiency acid lipase deficiency
the effect of controlled hypotension

Conditions: Cerebral Hypoperfusion; Hypotension

Summary: controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. one such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rso2). the aim of this study is to compare the effects of controlled hypotension at specific map ranges on cerebral oxygen saturation.

controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. one such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rso2). in the literature, various definitions of controlled hypotension exist. it is commonly defined as maintaining the mean arterial pressure (map) between 50-65 mmhg, systolic arterial pressure (sap) between 80-90 mmhg, or reducing map by 30% compared to baseline values. in our study, we plan to maintain the map within the range of 55-75 mmhg and compare the effects of two different map levels on perioperative cerebral oxygen saturation, anesthetic and surgical parameters, and postoperative cognitive functions. the aim of this study is to compare the effects of controlled hypotension at specific map ranges on cerebral oxygen saturation.

Eligibility criteria:
inclusion criteria: * aged 18-65 years * asa i-iii risk group * bmi between 18-40 * baseline blood pressure below 140/90 mmhg * scheduled to undergo spinal surgery (2-4 level instrumentation) exclusion criteria: * below 18 or above 65 years old * advanced comorbidities * asa iv or higher * baseline blood pressure above 140/90 mmhg * history of bleeding diathesis * use of anticoagulant medications * bmi below 18 or above 40 * history of previous spinal surgery

Keywords: cerebral oxygen saturation nirs controlled hypotension
study of postoperative nutritional support in cardiac surgery.

Conditions: Heart Diseases

Summary: the purpose of this study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition .


Eligibility criteria:
inclusion criteria: * absolute lymphocyte count \< 1500 * albumin \<35 g/l * body mass index\<21 kg/m2 * "b" class of nutritional status according to subjective global assessment exclusion criteria: * hepatitis b, c * total circulatory arrest * absence of informed consent signed * chronic liver diseases * gastric resection in patient's history * physical limitations of normal feeding